Design Quality Engineer - Medical Devices (14-Month)

Insight Global; Raynham (MA); On-site; USD 80,000 - 92,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

HSA

FSA

DCFSA

401k with employer matching

Paid time off

Job summary

Insight Global is seeking a design/quality engineer for the Spine product lifecycle, based in Massachusetts. The role focuses on leading design planning, requirements creation, and verification/validation activities for new and sustaining projects.

The engineer will drive risk management, apply statistical methods, and coordinate cross-functional reviews throughout the product development process to ensure compliance with QSR and ISO standards. A GMP/ISO background is essential.

Qualifications

• Bachelor’s degree in Engineering or Technical Science required.
• Minimum 3 years in GMP/ISO regulated industry preferred.
• Strong design/quality engineering skills across design control lifecycle.
• Experience in medical device/healthcare preferred.
• Solid knowledge of QSR (21 CFR 820) and ISO 13485, 14971 preferred.
• Blueprint literacy including GD&T preferred.

Responsibilities

• Join product development team focused on Spine business lifecycle management.
• Lead design and development planning for new and sustaining projects.
• Develop and validate functional/design requirements for projects.
• Conduct formal technical design reviews across development phases.
• Support design verification/validation including mechanical testing and analyses.
• Apply statistics and design-excellence tools to verification activities.
• Lead risk management planning and reporting across development and manufacturing.

Skills

GMP experience

Quality engineering

Design control

QSR (21 CFR 820)

ISO 13485/14971

GD&T literacy

Education

Bachelor’s Degree in Engineering/Technical Science

Master’s degree (plus)

Job description

Insight Global is seeking a design/quality engineer for the Spine product lifecycle, based in Massachusetts. The role focuses on leading design planning, requirements creation, and verification/validation activities for new and sustaining projects.

The engineer will drive risk management, apply statistical methods, and coordinate cross-functional reviews throughout the product development process to ensure compliance with QSR and ISO standards. A GMP/ISO background is essential.